PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

Inclusion criteria

• Histologically documented recurrent and/or metastatic non-small cell lung cancer
• Progression after prior PD-1 directed therapy (as monotherapy or in combination with chemotherapy and/or anti-CTLA4, or anti-VEGF agents) - defined as investigator assessed progression from prior treatment
• If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF, NTRK, progression on prior targeted therapy is required
• Measurable disease by RECIST 1.1
• ECOG Performance Status 0 or 1
• Signed written informed consent
• Minimum of 4 weeks from any other experimental anti-cancer therapies or prior PD-1 treatment
• Meet all the laboratory criteria per protocol

Exclusion criteria

• Prior treatment with PCSK9 inhibitors
• Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications.
• Uncontrolled diabetes mellitus, defined as HbA1c > 10
• Major surgery less than 4 weeks prior to study enrollment
• Another malignant condition diagnosed within 3 years of study enrollment
• Intolerance to prior PD-1/L1 treatment including discontinuation for severe or recurrent severe toxicity (including myocarditis or other myocardiotoxity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes, thrombocytopenia) or developed an immune checkpoint blockade related immune adverse event that was refractory to steroids and required additional systemic immunosuppressive medication.
• Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS)
• Additional exclusion criterion as per listed in the protocol